Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Chinese ethnicity;

• History of allergic conjunctivitis within the last 2 years;

• Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit;

• Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;

• Understand and sign an informed consent form;

• Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Contraindications or hypersensitivity to study medications or their components;

• Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;

• Any ocular condition that could affect the study outcomes;

• Presumed or actual ocular infection or history of ocular herpes in either eye;

• Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;

• Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products);

• Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease;

• Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit;

• Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator;

• Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit;

• Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids;

• Use of cold compresses on the eyes during the course of the study;

• Cannot be dosed in both eyes;

• Cannot avoid contact lens wear during the course of the study;

• Therapy with another investigational agent within 30 days of baseline visit, or during the study;

• Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods;

• Other protocol-specified exclusion criteria may apply.